Full text is available at the source.
Health technology assessment (Winchester, England)··
Goal-focused thinking training for early Alzheimer's and similar dementias: the GREAT trial
Updated
Abstract
A total of 475 participants were randomised to receive either cognitive rehabilitation or treatment as usual.
- Cognitive rehabilitation resulted in statistically significant improvements in participant-rated goal attainment at 3 months (mean change of 2.57 in the CR group versus 0.86 in TAU).
- Carer ratings also indicated large positive effects on goal attainment, corroborating participant reports.
- The improvements in goal attainment were maintained at 9 months for both participants and carers.
- No significant differences were observed in secondary outcomes related to quality of life, mood, self-efficacy, or carer stress.
- Cognitive rehabilitation showed cost-effectiveness regarding participant-rated goal attainment at willingness-to-pay values of £2500 or more, but not for quality-adjusted life-years.
Simplified
BACKGROUND: Cognitive rehabilitation (CR) is an individualised, person-centred intervention for people with mild to moderate dementia that addresses the impact of cognitive impairment on everyday functioning.
OBJECTIVES: To determine whether or not CR is a clinically effective and cost-effective intervention for people with mild to moderate Alzheimer's disease or vascular or mixed dementia, and their carers.
DESIGN: This multicentre randomised controlled trial compared CR with treatment as usual (TAU). Following a baseline assessment and goal-setting to identify areas of everyday functioning that could be improved or better managed, participants were randomised (1 : 1) via secure web access to an independent randomisation centre to receive either TAU or CR and followed up at 3 and 9 months post randomisation.
SETTING: Community.
PARTICIPANTS: Participants had an, Tenth Edition, diagnosis of Alzheimer's disease or vascular or mixed dementia, had mild to moderate cognitive impairment (Mini Mental State Examination score of ≥ 18 points), were stable on medication if prescribed, and had a family carer who was willing to contribute. The exclusion criteria were people with a history of brain injury or other neurological disorder and an inability to speak English. To achieve adequate power, we needed 350 people to complete the trial, with 175 people in each trial arm. International Classification of Diseases
INTERVENTION: Cognitive rehabilitation consisted of 10 therapy sessions over 3 months, followed by four maintenance sessions over 6 months, delivered in participants' homes. The therapists were nine occupational therapists and one nurse.
OUTCOME MEASURES: The primary outcome was self-reported goal attainment at 3 months. Goal attainment was also assessed at 9 months. Carers provided independent ratings of goal attainment at both time points. The secondary outcomes were participant quality of life, mood, self-efficacy and cognition, and carer stress, health status and quality of life. The assessments at 3 and 9 months were conducted by researchers who were blind to the participants' group allocation.
RESULTS: A total of 475 participants were randomised (CR arm, = 239; TAU arm, = 236), 427 participants (90%) completed the trial and 426 participants were analysed (CR arm, = 208, TAU arm, = 218). At 3 months, there were statistically significant large positive effects for participant-rated goal attainment [mean change in the CR arm: 2.57; mean change in the TAU arm: 0.86; Cohen's = 0.97, 95% confidence interval (CI) 0.75 to 1.19], corroborated by carer ratings (Cohen's = 1.11, 95% CI 0.89 to 1.34). These effects were maintained at 9 months for both the participant ratings (Cohen's = 0.94, 95% CI 0.71 to 1.17) and the carer ratings (Cohen's = 0.96, 95% CI 0.73 to 1.20). There were no significant differences in the secondary outcomes. In the cost-utility analyses, there was no evidence of cost-effectiveness in terms of gains in the quality-adjusted life-years (QALYs) of the person with dementia (measured using the DEMentia Quality Of Life questionnaire utility score) or the QALYs of the carer (measured using the EuroQol-5 Dimensions, three-level version) from either cost perspective. In the cost-effectiveness analyses, by reference to the primary outcome of participant-rated goal attainment, CR was cost-effective from both the health and social care perspective and the societal perspective at willingness-to-pay values of £2500 and above for improvement in the goal attainment measure. There was no evidence on the cost-effectiveness of the self-efficacy measure (the Generalized Self-Efficacy Scale) from either cost perspective. n n n n d d d d
LIMITATIONS: Possible limitations arose from the non-feasibility of using observational outcome measures, the lack of a general measure of functional ability and the exclusion of people without a carer or with rarer forms of dementia.
CONCLUSIONS: Cognitive rehabilitation is clinically effective in enabling people with early-stage dementia to improve their everyday functioning in relation to individual goals targeted in the therapy sessions.
FUTURE WORK: Next steps will focus on the implementation of CR into NHS and social care services and on extending the approach to people with rarer forms of dementia.
TRIAL REGISTRATION: Current Controlled Trials ISRCTN21027481.
FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in; Vol. 23, No. 10. See the NIHR Journals Library website for further project information. Health Technology Assessment
Related papers
Apr '19
Group memory training program for people with traumatic brain injuries: the ReMemBrIn trial
cited by 9 papers
randomized controlled trial
May '22
Helping people with early-stage dementia manage their condition and stay independent: the Journeying through Dementia trial
cited by 7 papers
randomized controlled trial
Feb '19
Personalized thinking skill training to improve daily life in people with early dementia: A large clinical trial
cited by 132 papers
randomized controlled trial
Jan '20
Group cognitive rehabilitation to improve quality of life in people with multiple sclerosis: the CRAMMS clinical trial
cited by 19 papers
randomized controlled trial
Jun '18
Exercise program combining aerobic and strength training for thinking problems in people with mild to moderate dementia
cited by 48 papers
randomized controlled trial
May '20
Longer stroke rehabilitation support for stroke survivors: the EXTRAS clinical trial
cited by 15 papers
randomized controlled trial
Sep '19
Testing activity-based therapy for depression after stroke: a feasibility trial
cited by 55 papers
randomized controlled trial
May '19
Phone and online cognitive therapy compared to usual care in hard-to-treat irritable bowel syndrome
cited by 34 papers
randomized controlled trial
Aug '15
Effectiveness and cost of personalized brain stimulation therapy for dementia in a large clinical trial
cited by 83 papers
randomized controlled trial